Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT00173693 |
| Other study ID # |
9461700347 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
September 12, 2005 |
| Last updated |
December 6, 2012 |
| Start date |
January 2006 |
| Est. completion date |
December 2010 |
Study information
| Verified date |
November 2012 |
| Source |
National Taiwan University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Taiwan: Department of Health |
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to conduct a cost-effectiveness analysis (CEA) among the programs for
preventing osteoporotic fracture. The main comparison will be made among the effects of
three programs for preventing osteoporotic fractures: 1. health education; 2. exercise
intervention for enhancing bone mineral density (BMD); 3. exercise intervention for
preventing falls. The "cost" will be measured bases on the monetary cost of implementation
of each program. The "effectiveness" will be measured includes the number of prevented
osteoporotic fractures of each program, and related outcomes are the follows: 1. the medical
cost of osteoporotic fracture; 2. the change of BMD in consecutive years; 3. the quality of
life (QOL) of patients with osteoporotic fracture as compared to the reference population.
Description:
This study aims to conduct a cost-effectiveness analysis (CEA) among the programs for
preventing osteoporotic fracture. The main comparison will be made among the effects of
three programs for preventing osteoporotic fractures: 1. health education; 2. exercise
intervention for enhancing bone mineral density (BMD); 3. exercise intervention for
preventing falls. The "cost" will be measured bases on the monetary cost of implementation
of each program. The "effectiveness" will be measured includes the number of prevented
osteoporotic fractures of each program, and related outcomes are the follows: 1. the medical
cost of osteoporotic fracture; 2. the change of BMD in consecutive years; 3. the quality of
life (QOL) of patients with osteoporotic fracture as compared to the reference population.
First year (2006): mainly a preparation stage
1. To conduct a meta-analysis of the effects of various interventions of prevention of
osteoporotic fracture, especially in exercise models.
2. To establish the exercise programs for the intervention in the 2nd year, including the
booklets and the posters.
3. To review the other alternatives of prevention of osteoporotic fracture.
4. To establish the social network needed for the following research. Second year (2007):
to start the community-based field studies in Neihu District, Taipei.
All 37 "Lis" in Neihu will be invited to join the study, but only the Lis with willingness
of participation will be the units for cluster sampling, and will be randomized to the three
programs (Li as a unit). People living in the sampled Lis meet the inclusion criteria
(postmenopausal (minimum for 1year) women and men over 65 years old) will be recruited and
they will be further randomized into intervention group or reference group within each
program.
1.To collect the baseline data. Baseline data include: the BMD, physical activity, nutrition
diary, muscle strength, balance, risk factors of osteoporosis, history of fractures and
falls 2.To execute the interventions. Three programs will be executed in the sampled Lis.
They are all designed as a randomized control trial.
1. Health education (HE trial): lectures on knowledge of osteoporosis, osteoporotic
fracture, the risk factors, the nutritional demand, the exercise principles for
enhancing BMD and preventing fall.
2. Intervention for enhancing BMD (BMD trial): interventions to emphasize on
weight-bearing exercise and trunk stabilization exercises. The exercise program will be
supervised by a professional physical therapist 3 times per week for 3 months.
3. Intervention for preventing falls (fall prevention trial): interventions to emphasize
on balance and strength training exercises. The exercise program will be also
supervised by a professional physical therapist 3 times per week for 3 months.
3.To apply the NHRI released health insurance data (2002-2006) for the next year study
Third year (2008): follow-up, cost calculation and study on medical cost
1. To calculate the cost of three intervention programs (from the view of provider).
2. Telephone follow-up (FU) and recording the incidence of fall & fracture every 3
months.
3. The first FU (1st FU) of the items collected at baseline.
4. To study the medical cost of osteoporotic fracture with NHRI data. Fourth year
(2009): continuing follow-up and study on QOL
1. Continuing the telephone FU and recording the incidence of fall & fracture every 3
months
2. The second FU (2nd FU) of the items collected at baseline
3. To conduct a survey for the health-related QOL of people with osteoporotic
fracture from outpatient clinics in hospital and the newly fractured subjects in
the community.
Fifth year (2010): continuing follow-up and CEA
1. Continuing the telephone FU and recording the incidence of fall & fracture every 3
months.
2. The third FU (3rd F/U) of the items collected at baseline.
3. To investigate the effects of each intervention program
